CALM Breathing for COPD
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- COPD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A prospective RCT: In Phase I, participants will be randomized 1:1 to one of two groups: CALM Breathing (N = 25) and Wait-List control (N = 25). In Phase II, both groups will be offered Rusk's 10-week PR program (care as usual). Access to timely initiation of PR will be facilitated. We will use a hybrid design to evaluate feasibility and acceptability.Masking: Single (Participant)Masking Description: Outcome assessmentPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The purpose of this pilot study is to establish success benchmarks of CALM Breathing and to test feasibility of: recruiting a target group of adults with COPD and concurrent anxiety, including building a partnership with the NYU Pulmonary department; ensuring adequacy of recruitment and study referr...
The purpose of this pilot study is to establish success benchmarks of CALM Breathing and to test feasibility of: recruiting a target group of adults with COPD and concurrent anxiety, including building a partnership with the NYU Pulmonary department; ensuring adequacy of recruitment and study referral procedures; ASI-16 anxiety sensitivity cut-point for eligibility; randomizing participants to CALM Breathing and Wait-List; assessment procedures; confirming our estimates of time needed to administer assessments; evaluating participant ratings of assessment burden; and testing that target timelines and blinding are achievable; facilitating timely PR intake assessment initiation (to limit wait); implementing manualized CALM Breathing, including adequacy of dose (timing, frequency, and session duration), fidelity procedures, and transportation funds; attention will be given to additional considerations and tailoring needs of patients with significant anxiety sensitivity and/or anxiety disorders; implementing home-based breathing exercise component (e.g., new RR device fidelity checks and new distribution of therapist-guided audio exercises using an MP3 player to improve adherence rate) retaining participants at 3-month follow-up post-PR, including ensuring adequacy of retention strategies.
Tracking Information
- NCT #
- NCT04786184
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Anna Norweg, PhD, OTR NYU Langone Principal Investigator: Naomi Simon, MD NYU Langone
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